Evidence map›Paper›PMID 29995008›Full record

Trial reportOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2018

Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial.

Tim G A Calon, Martin L Johansson, Arthur J G de Bruijn, Herbert van den Berge, Mariet Wagenaar, Edwin Eichhorn, Miranda M L Janssen, Janny R Hof, Jan-Wouter Brunings, Manuela A Joore and 4 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Punch vs open surgical techniques for placement of bone-anchored hearing implants: a systematic review and meta-analysis of skin reactions and operating time.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2021
    Pooled it
  2. Pooled it
  3. Ten years of experience with the Ponto bone-anchored hearing system-A systematic literature review.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2020
    Pooled it
  4. Article
  5. Pain and infection are the primary reasons for elective retrieval of bone-anchored implants.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Article
  6. Article
  7. Long-Term Clinical Outcomes for Bone-Anchored Hearing Implants: 3-Year Comparison Between Minimally Invasive Ponto Surgery and the Linear Incision Technique With Tissue Preservation.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2025
    Article
  8. Article
  9. Article
  10. In-office Bone-Anchored Hearing Implants via Minimally Invasive Punch Technique in a Veteran Population.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2022
    Article
  11. Article
  12. Frontiers in surgery · 2022
    Article
  13. Article
  14. Article
  15. Comparison between linear incision and punch techniques for bone anchored hearing aid surgery.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2021
    Article
  16. Review
  17. Article
  18. Long-term soft tissue outcomes for hydroxyapatite-coated bone-anchored hearing implant surgery.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2019
    Article
  19. Bone Conduction Implants for Hearing Rehabilitation in Skull Base Tumor Patients.Journal of neurological surgery. Part B, Skull base · 2019
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Tim G A CalonDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Martin L JohanssonDepartment of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg.
Arthur J G de BruijnDepartment of Otorhinolaryngology, ZiekenhuisGroep Twente, Almelo.
Herbert van den BergeDepartment of Otorhinolaryngology, Medisch Centrum Leeuwarden, Leeuwarden.
Mariet WagenaarDepartment of Otorhinolaryngology, Medisch Centrum Leeuwarden, Leeuwarden.
Edwin EichhornDepartment of Otorhinolaryngology, Medisch Centrum Leeuwarden, Leeuwarden.
Miranda M L JanssenDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Janny R HofDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Jan-Wouter BruningsDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Manuela A JooreDepartment of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Centre.
Sofia JonhedeOticon Medical AB, Askim, Sweden.
Joost van TongerenDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Marcus HolmbergOticon Medical AB, Askim, Sweden.
Robert-Jan StokroosDepartment of Otorhinolaryngology, Head and Neck Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).

designSponsor-initiated multicenter, open, randomized, controlled clinical trial.

settingMaastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.

participantsSixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group. PRIMARY AND SECONDARY OUTCOME MEASUREMENTS: Primary objective: compare the incidence of inflammation (Holgers Index ≥ 2) during 12 weeks' follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.

resultsSixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.

conclusionNo significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.

Indexed as

Bone ConductionCochlear ImplantsOrgan Sparing TreatmentsAdolescentAdultCochlear ImplantationFemaleHumansMaleMiddle AgedMinimally Invasive Surgical ProceduresPostoperative ComplicationsSuture AnchorsTreatment OutcomeYoung Adult

Identifiers

PMID29995008
PMCPMC6075882

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.